IEC 62304 requires the software system test and its documentation – since amendment A1:2016 for all software classes, from A to C. What is required is not just “passed”, but end-to-end evidence: which requirement, which test case, which result, at which device state. XPressRT runs the system test on the finished device and records exactly this evidence while you test – documenting the system test as it runs, instead of reconstructing it afterwards.
Standard
What IEC 62304 requires of the system test
System test for all classes
Since IEC 62304 A1:2016 the software system test is required for classes A, B and C, no longer only for B and C.
Documented results
What is required is evidenced results per test case – measured value, criterion, outcome – not just a tick.
End-to-end links
Requirement, test case and result must connect traceably so the evidence holds in an audit.
Traceable per device state
Every result carries which firmware state and which device it came from.
What we deliver
What XPressRT provides for it
An audit-ready record per unit
Each tested medical device gets a readable document – serial number, firmware, measured value against limit, tester and date.
Mixed test procedures
Manual operator steps and automated device steps run in one procedure and one record.
Findings, not just red steps
Deviations are documented with conditions and reproduction and attached to the report.
Bring over Word and Excel
Existing test procedures are imported and proposed for confirmation. Your release stays decisive.
You would rather not build the test setup and the evidence yourself? We take on the test environment as a whole.
Classification
Two levels of evidence for the same requirement
The system test on the finished device is one level. The other is verification of the firmware at signal level – reproducible, with deliberate fault injection, without a real patient device. That is Hardware-in-the-Loop with LoopCheck. Both levels evidence the same requirement, in different ways.
Scope
What XPressRT does not replace
XPressRT is not a requirements or quality management system. Your requirements stay in Polarion, Codebeamer, Jama or DOORS; XPressRT reads from them and writes nothing back. It lays the execution and evidence layer on top, where you test. And XPressRT does not make you “compliant” – it delivers the documented evidence the standard requires. Approval remains your responsibility.
Frequently asked questions about the IEC 62304 system test
Does IEC 62304 require a software system test?
Yes. IEC 62304 requires the software system test; since amendment A1:2016 for all software classes (A, B, C). Results must be documented and linked to requirements and test cases.
How do I document the system test to IEC 62304?
By producing an audit-ready record per tested unit: measured value against limit, serial number, firmware state, tester and date, with documented findings for deviations. XPressRT records this while you test, not in rework afterwards.
Which software classes does the system test apply to?
Since IEC 62304 A1:2016 for classes A, B and C. Scope and depth depend on the class and the risk.
Does XPressRT replace HIL verification of the firmware?
No. XPressRT documents the system test on the finished device. Firmware verification at signal level is done by Hardware-in-the-Loop (LoopCheck). The two complement each other as two levels of evidence.
Can I bring over existing procedures from Word or Excel?
Yes. You give the document to your AI assistant – which runs at your end, not ours – and get steps, limits and instruments proposed for confirmation. The source file stays attached as evidence.
Let the evidence appear at the device
XPressRT runs the system test on the device and records the evidence as it goes – reading against limit, serial number, firmware, tester. In the browser, no installation and no account. Open it and create a procedure right away.